Expanded acute toxicity by intranasal administration of SURFACEN® in rats

Abstract

Local irritability studies for inhaled products constitute a fundamental link in the chain of regulatory requirements for preclinical toxicological studies. For this reason, the objective of the work was to determine the irritation potential of SURFACEN^® in repeated doses by intranasal route. Thirty Cenp: Sprague Dawley rats (15/sex) were divided into two experimental groups: control (0.9 % NaCl solution) and treated (SURFACEN^®). Both groups received the same treatment scheme with two daily intranasal applications spaced four to six hours apart, for 14 days. The dose to be applied was 13.27 mg/kg. Clinical observations, body weight, post mortem body weight, absolute and relative weight of the selected organs (lungs, brain) of each animal and pathological study were the variables to be studied. The design and implementation of the research was carried out according to the animal welfare principles. All animals survived the study. No statistically significant differences were evidenced between both groups regarding the variables studied. There were no signs of overt toxicity after SURFACEN^® administration, and no anatomopathological alterations that could be associated with the administration of the drug were detected. It was evidenced that the application of repeated doses of SURFACEN^® by intranasal route did not alter the cell morphology of the nasal mucosa, did not cause histopathological damage in the organs studied and did not produce signs of local irritation, thus it is considered potentially non-toxic for humans.